Key highlights

• United States: DKK 2,498 million (+9% CER; +7% DKK)
• Europe: DKK 1,248 million (+9% CER; +6% DKK)
• International Markets: DKK 1,481 million (+4% CER; -1% DKK)

• Brintellix[®]/Trintellix[®]: DKK 1,168 million (+11% CER; +8% DKK)
• Rexulti[®]: DKK 1,115 million (+7% CER; +5% DKK)
• Abilify Maintena[®]/Asimtufii: DKK 859 million (+10% CER; +9% DKK)
• Vyepti[®]: DKK 617 million (+79% CER; +76% DKK)

Adjusted EBITDA[2] decreased to DKK 1,746 million (-2% CER; -5% DKK) as a result of a lower adjusted gross margin, following quarterly fluctuations in stock valuation. In addition, the first quarter of 2024 reflects higher R&D costs to support the pipeline in progress and targeted investments in sales and promotion mainly for Rexulti[®] and Vyepti[® ]in the U.S.

Adjusted EBITDA margin reached 33.0% equivalent to a decrease of 3.6 percentage points. Adjusted earnings per share (EPS) reached DKK 1.38 (+1%). Excluding the effect from quarterly fluctuations in stock valuation, the underlying growth in the adjusted EBITDA was 6% CER, constituting an adjusted EBITDA margin decrease of 0.6 percentage points.

In connection with the corporate release, Lundbeck's President and CEO, Charl van Zyl said:

"I am pleased to present another solid quarter for Lundbeck with a robust operational performance and a 7% revenue growth driven by the continued strong performance of our strategic brands. In line with our Focused Innovator strategy, we are driving forward promising scientific innovations such as our potential first-in-class therapy for migraine prevention, anti-PACAP, and a possible first treatment option targeting the rare neurological condition, Multiple System Atrophy."
 

Key figures

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DKK million Q1 2024 Q1 2023 Change Change(DKK)
(CER)[1]
Revenue 5,288 5,044 7% 5%
EBITDA 1,746 1,744 4% 0%
Adjusted EBITDA 1,746 1,845 (2%) (5%)
EPS (DKK) 1.01 0.89 13%
Adjusted EPS (DKK) 1.38 1.36 1%

Recent events

On 30 April 2024, U.S. Food and Drug Administration (FDA) communicated to Lundbeck that Lu AF82422 orphan drug designation request has been granted for treatment of Multiple System Atrophy (MSA).

On 9 April 2024, Lundbeck and Otsuka Pharmaceutical Co., Ltd. submitted a supplemental New Drug Application (sNDA) for U.S. FDA review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults. The sNDA submission is based on previously disclosed results, including data from the two clinical phase III trials and the clinical phase II trial. All three trials investigated the treatment of PTSD in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo.

On 27 March 2024, Lundbeck and Otsuka Pharmaceutical Europe Ltd. announced that the European Commission (EC) has approved Abilify Maintena[®] 960 mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for the maintenance treatment of schizophrenia in adult patients stabilized with aripiprazole. The EC decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.

On 15 March 2024, Lundbeck announced the advancement of the clinical development of Lu AG09222 for migraine prevention with the initiation of PROCEED, a randomized, double-blind, phase IIb, dose-finding trial to assess efficacy and safety of multiple subcutaneously administered doses. The PROCEED trial builds on the positive results of the HOPE phase IIa Proof-of-Concept trial demonstrating efficacy of intravenously administered Lu AG09222 in migraine prevention.

On 5 March 2024, Lundbeck announced clinical data from the AMULET phase II, double-blind, randomized trial of Lu AF82422 in MSA at the International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD 2024). Based on the encouraging AMULET trial outcomes, Lundbeck plans to initiate a phase III study, following further dialogue with health authorities.

Lundbeck announced key leadership changes on 23 February 2024. Michala Fischer-Hansen joined as Executive Vice President and Head of Europe & International Markets. Additionally, Tine Østergaard Hansen and Dianne Hol were appointed Senior Vice President of Corporate Communication & Public Affairs and Executive Vice President of People & Organization, respectively. Furthermore, on 13 May 2024, Lundbeck announced the appointment of Maria Alfaiate as Executive Vice President Commercial and Corporate Strategy.

Financial guidance 2024 maintained

On 7 February 2024, Lundbeck communicated the financial guidance for 2024 focusing on revenue performance and adjusted EBITDA at CER.

The revenue growth is expected to be 7% to 10% at CER when compared to revenue of the prior year excluding the effect from hedging. The adjusted EBITDA growth is expected to be 10% to 16% at CER when compared to adjusted EBITDA of the prior year excluding effects from hedging. Further details are available in section 2.7 Outlook.

[1] Change at CER (Constant Exchange Rates) does not include effects from hedging.

[2] EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section 4 Notes, note 3 Adjusted EBITDA.